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Bosentan Pregnancy and Breastfeeding Warnings

Brand names: Tracleer

Medically reviewed by Last updated on Jul 7, 2023.

Bosentan Pregnancy Warnings

Use in women who are or may become pregnant is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: X

-Effective contraception (at least 2 reliable forms) is required during therapy and for 1 month after the last dose; some experts recommend to avoid becoming pregnant for 3 months after conclusion of therapy.
-Treatment should be initiated in women of reproductive potential only after a negative pregnancy test is obtained; a prescription should not be dispensed without documenting a negative pregnancy test performed during the first 5 days of a normal menstrual period and at least 11 days after the last unprotected act of sexual intercourse.
-Follow-up pregnancy tests should be obtained monthly in females of reproductive potential.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of teratogenicity, including malformations of the head, mouth, face, and large blood vessels. Increased stillbirths and pup mortality were observed when this drug was given at 2 and 10 times the maximum recommended human dose. Decreased sperm counts and adverse effects on spermatogenesis have been reported. There are no controlled data in human pregnancy.

This drug can reduce serum levels of estrogen and progestin in oral contraceptives and thus hormonal contraceptives (including oral, injectable, transdermal, and implantable contraceptives) may be less effective for preventing pregnancy in patients using this drug and should not be used as a patient's only contraceptive method. Patients may choose one highly effective form of contraception (intrauterine devices or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Bosentan Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

Due to limited published experience regarding use of this drug during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. (2001) "Product Information. Tracleer (bosentan)." Actelion Pharmaceuticals US Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Tracleer (bosentan)." Actelion Pharmaceuticals US Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.